A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01171781
First received: July 27, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

The study try to show the weekly cisplatin based CCRT is not inferior to 3-weekly cisplabe based CCRT in terms of 3-yr progression free survival rate in advanced nasopharyngeal carcinoma


Condition Intervention Phase
Nasophayngeal Carcinoma Between Stage II and IVb
Drug: cisplatin (3 weekly)
Drug: cisplatin (weekly)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • progression free survival rate at 3 years [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • objective response rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: November 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 3 weekly CDDP based CCRT
radiation (conventioal or IMRT) with 3 cycles of 3-weekly cisplatin
Drug: cisplatin (3 weekly)
radiation with cisplatin (100mg/m2) on D1,D22,D43 and followed by adjuvant chemotherapy (3 cycles of FP)
Experimental: weekly cisplatin based CCRT
radiation (conventional or IMRT) with 7 cycles of weekly cisplatin therapy
Drug: cisplatin (weekly)
radiation with 7 cycles of cisplatin (40mg/m2) on D1,8,15,22,29,36,43, and followed by adjuvant chemothrapy (FP X3)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed nasopharyngeal carcinoma age of 18 years or over stage II ~ IVb no history of chemotherapy, radiotherapy, or immunotherapy for NPC with measurable lesion based on RECIST 1.1 ECOG PS 0 ~2 good organ function (liver, renal, hematologic)

Exclusion Criteria:

  • active infectious disease requiring antibiotics uncontrolled heart disease pregnancy and on feeding state history of other malignancy within 5 years before enrollment, except for well treated non-melanomatous skin cancer, in situ cervical cancer, thyroid cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171781

Contacts
Contact: Myung-Ju Ahn, M.D, Ph.D. 822-3410-3438 silkahn@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Myung-Ju Ahn, M.D., Ph.D.    822-3410-3438    silkahn@skku.edu   
Principal Investigator: Myung-Ju Ahn, M.D., Ph.D.         
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Myung-Ju Ahn, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01171781     History of Changes
Other Study ID Numbers: 2009-09-037
Study First Received: July 27, 2010
Last Updated: July 27, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014